Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

viatrexx bio incorporated - sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), bos taurus adrenal gland (unii: m2776swb29) (bos taurus adrenal gland - unii:m2776swb29), azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt), bos taurus skin (unii: 7j12cd6o9l) (bos taurus skin - unii:7j12cd6o9l), copper (unii: 789u1901c5) (copper - unii:789u1901c5), cysteine (unii: k848jz4886) (cysteine - unii:k848jz4886), fumaric acid (unii: 88xhz13131) (fumaric acid - unii:88xhz13131), glutathione (uni - viatrexx-pigmentation  a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an iv, either as a push or into the bag. this product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. as with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection. this product contains 1% benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. due to the benzyl alcohol content, this product should not be given to a pregnant woman. this product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or pat

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

leo pharma inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - finacea gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the mrhd based on body surface area (bsa) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the mrhd based on bsa comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the mrhd based on bsa comparison) azelaic acid. no malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. an oral peri- and post-natal developmental study was conducted in rats. azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the mrhd based on bsa comparison) that generated some maternal toxicity. in addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the mrhd based on bsa comparison). no effects on sexual maturation of the fetuses were noted in this study. risk summary azelaic acid is naturally present in human milk. when used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to finacea gel. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for finacea gel and any potential adverse effects on the breastfed child from finacea gel or from the underlying maternal condition. the safety and effectiveness of finacea gel have not been established in pediatric patients. clinical studies of finacea gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

leo pharma inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - finacea foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarria

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

a-s medication solutions - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - finacea gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of major b

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

skinfix, inc. - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - acne treatment helps clear acne blemishes and allows skin to heal. helps keep skin clear of new acne blemishes. helps prevent new acne blemishes from forming.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

skinfix, inc. - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - acne treatment helps clear acne blemishes and allows skin to heal. helps keep skin clear of new acne blemishes. helps prevent new acne blemishes from forming.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

anubis cosmetics sl - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt), polyethylene glycol 400 (unii: b697894sgq) (polyethylene glycol 400 - unii:b697894sgq), propylene glycol (unii: 6dc9q167v3) (propylene glycol - unii:6dc9q167v3), isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302), water (unii: 059qf0ko0r) (water - unii:059qf0ko0r), salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz), alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

psodex usa inc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1), azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - condition worsens or does not improve after regular use of this product as directed. treats and controls symptoms of rosacea reduces redness and inflammation associated with rosacea promotes even skin tone minimizes the appearance of blood vessels

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

hero cosmetics, inc. - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - - for the treatment of acne - clears acne blemishes and allows skin to heal - helps prevent new acne blemishes from forming

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cp skin health group, inc - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - salicylic acid 2.0 g in 100 ml - uses: - clears and reduces the severity of acne blemished - penetrates pores to help prevent development of new blemishes/blackheads.